FDA Approval and Post-Marketing Files for Midodrine – NDA, AE Reports, and Advisory Meeting Documents

Original Request: Request 1: All documents related to the approval process of midodrine, including the New Drug Application (NDA) and any amendments or supplements. This includes clinical trial data, safety evaluations, and correspondence with the manufacturer. Request 2: All post-marketing surveillance data and adverse event reports for midodrine. Request 3: Internal FDA communications or documents that discuss the safety profile of midodrine, including any risks or concerns. These could include memoranda, emails, or risk assessments, offering insights into the FDA's ongoing evaluation of the drug's safety. Request 4: Documents related to the FDA's consideration of withdrawing approval for midodrine in 2010 and the subsequent reversal. Request 5: Any studies or data on off-label use of midodrine that have been submitted to or collected by the FDA. Request 6: Correspondence between the FDA and the manufacturer regarding any safety concerns or potential new indications for midodrine. Request 7: FDA advisory committee meeting minutes or transcripts where midodrine is discussed.
Tags: Pharma, NDA, 2010